deutsche akkreditierungsstelle gmbh - gfps

The management system requirements of DIN EN ISO/IEC 17025 are written in the language relevant to the operations of testing laboratories. Laboratories that conform to the requirements of this standard, operate generally in accordance with the principles of DIN EN ISO 9001. The certificate together with the annex reflects the status as indicated by the date of issue. The current status of any given scope of accreditation may be found respectively in the database of accredited bodies of Deutsche Akkreditierungsstelle GmbH https://www.dakks.de/en/content/accredited-bodies-dakks.

Abbreviations used: see last page Page 1 of 7 This document is a translation. The definitive version is the original German annex to the accreditation certificate.

Deutsche Akkreditierungsstelle GmbH

Annex to the Accreditation Certificate D-PL-13422-01-00 according to DIN EN ISO/IEC 17025:20181 Valid from: 12.05.2021

Date of issue: 12.05.2021

Holder of certificate:

GfPS Gesellschaft für Produktionshygiene und Sterilitätssicherung mbH Talbotstraße 21, 52068 Aachen

Field: Medical devices and the Directive 93/42/EEC23 on independence

Testing fields/test items: Microbiological-hygienic tests of Medical devices,

cleaning devices, Sterilization processes as well as microbiological-hygienic and physical tests of sterile barrier and packaging systems; Environmental monitoring

https://www.dakks.de/en/content/accredited-bodies-dakks

Annex to the accreditation certificate D-PL-13422-01-00

Valid from: 12.05.2021 Date of issue: 12.05.2021 Page 2 of 7

- Translation -

Testing categories Device category Characteristics/ Test options

Standard method of testing

Microbiological hygienic testing

Medical devices Sterility test DIN EN ISO 11737-2

Ph. Eur. 2.6.1

USP <71>

Total aerobic microbial count Ph. Eur. 2.6.12

USP <61>

Test for particular microorganisms

Ph. Eur. 2.6.13

USP <62>

- Enterobacteriaceae SOP 120

- Salmonellae

- Pseudomonas aeruginosa

- Staphylococcus aureus

- Eschericha coli

Test for adequate antimicrobial preservation

Ph. Eur. 5.1.3

USP <51>

Sterilization processes

Tests within the context of routine monitoring

- by moist heat - by means of biological indicators

DIN EN ISO 17665-1

SOP 109

other applicable documents:

DIN EN 285

- by dry heat - by means of biological indicators

SOP 109

- by ethylene oxide - by means of biological indicators

DIN EN ISO 11135

SOP 109



- Translation -

Testing categories Device category Characteristics/ Test options



Cleaning devices Tests within the context of routine monitoring

- decontamination systems for mechanically decontaminable mattresses

- by means of biological indicators

SOP 147 Directive of BGA thermal disinfection processes and cleaning machines AK-BWA, Part 8

- decontamination systems for bed frames and bedside tables



- decontamination systems for circulation containers



Sterile barrier- and packaging systems, packaging materials

Test for conformity

DIN EN ISO 11607-1

- Micobiological barrier DIN 58953-6 ASTM F 1608 SOP 169

Physical testing Sterile barrier- and packaging systems, packaging materials

Test for conformity DIN EN ISO 11607-1

- Accelerated aging ASTM F 1980

- Seal strength N EN 868-5 ASTM F 88/ F 88M

- Integrity of the sterile barrier seal

ASTM F 1886 / F 1886M ASTM F 1929 ASTM F 3039

- Integrity of the sterile

barrier system

ASTM F 2096



- Translation -

Testing categories Device category Characteristics/

Test options


Physical testing Sterile barrier- and packaging systems, packaging materials

Real time aging SOP 160

(ASTM F 1980)

Environmental Monitoring by Production and Testing of Product Cleanliness according to DIN EN ISO 13485:2016-084, Par. 6.4 und Par. 7.5


Medical devices Test for bacterial endotoxins (LAL –Test)

Ph. Eur. 2.6.14

USP <85>

Determination of a population of microorganisms on products

DIN EN ISO 11737-1

Air conditioning systems

Clean-room monitoring DIN EN ISO 14644-1

DIN EN ISO 14644-2 DIN EN ISO 14644-3

DIN EN ISO 14644-4

VDI 6022 Blatt 1

VDI 2083 Blatt 3

Microbiological examination of air

DIN EN ISO 14698-1

DIN EN ISO 14698-2

DIN 1946-4

VDI 2083 Blatt 3

Microbiological examination of surfaces

DIN EN ISO 14698-1

DIN EN ISO 14698-2

Semi-quantitative microbial enumeration in compressed air

SOP 119

SOP 120

Water and aqueous solutions

Counting the total viable aerobic microorganisms capable of reproduction

Ph. Eur. 2.6.12

USP <61>

SOP 120



- Translation -

Regulations:

DIN EN 285 : 2016-05 Sterilization – Steam sterilizers – Large-sterilizers

DIN EN 11135 : 2014-10 Sterilization of health care products - Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical device

DIN EN ISO 17665-1: 2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

DIN EN 868-5 : 2019-03 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

ISO 8573-7: 2003-05 Compressed air – Part 7: Test method for viable microbiological

DIN 1946-4: 2018-09 Ventilation and air conditioning - Part 4: Ventilation in buildings and rooms of health care

DIN EN ISO 11607-1: 2020-05 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

DIN EN ISO 11737-1: 2018-11 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

DIN EN ISO 11737-2 : 2010-04 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

DIN EN ISO 14644-1 : 2016-06 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

DIN EN ISO 14644-2 : 2016-05 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

DIN EN ISO 14644-3 : 2006–03 Cleanrooms and associated controlled environments - Part 3: Test methods

DIN EN ISO 14644-4 : 2003–06 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up

DIN EN ISO 14698-1 : 2004-04 Cleanrooms and associated controlled environments -Biocontamination control - Part 1: General principles and methods

DIN EN ISO 14698-2 : 2004-02 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data



- Translation -

DIN EN ISO 14698-2 : 2010-07

Corrigendum 1

Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data

DIN 58953-6 : 2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

AK-BWA Working Committee for Bedframe and Trolley Decontamination: mechanical cleaning and disinfection of bedframes, bedside tables, mattresses, trollies and circulatory containers

Bundesgesundheitsblatt, 23, 1980, pp. 364-367

ASTM F 1608 - 16 Standard Test Method for Microbial Ranking of Porous Packaging

ASTM F 1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for

ASTM F 88/F 88M - 15 Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F 1929 - 15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

ASTM F 1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems

ASTM F 2096 - 11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

ASTM F 3039 - 15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

Ph. Eur. 10.0, 2.6.1 Testing for sterility

Ph. Eur. 10.0, 2.6.12 Microbiological testing of non-sterile products: Counting the total number of germs capable of reproduction

Ph. Eur. 10.0, 2.6.13 Microbiological testing of non-sterile products: Detection of specified microorganisms

Ph. Eur. 10.0, 2.6.14 Testing for bacterial endotoxins

Ph. Eur. 10.0, 5.1.3 Testing for sufficient preservation

Directive of BGA thermal disinfection processes and cleaning machines

Guidelines from the Federal Ministry for Health for the testing of thermal disinfection processes and cleaning machinery (Complied from the comments on the guidelines of the BGA for the testing of thermal disinfection processes and cleaning machinery

Bundesgesundheitsblatt, 23, 1980, pp. 364-367

SOP 109 REV T Microbiological in - process control of EO-/steam-/heat-/ plasma sterilization



- Translation -

SOP 119 REV H Semi-quantitative determination of the microbial count in compressed air

SOP 120 REV K Microbiological Differentiation

SOP 147 REV I Testing of dishwashers, disinfection machine and disinfection facilities for trollies and bedframes using bioindicators

SOP 160 REV L Packaging tests

SOP 169 REV G Testing of microbial barrier behaviour by microbiological dusting

USP 42, <51> : 2018 Antimicrobial Effectiveness Test

USP 42, <61> : 2018 Microbiological Examination of Non-Sterile Products: Microbial

USP 42, <62> : 2018 Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms

USP 42, <71> : 2018 Sterility Tests

USP 42, <85> : 2018 Bacterial Endotoxins Test

VDI 2083 Blatt 3: 2005-07 Cleanroom technology - Metrology and test methods

VDI 6022 Blatt 1: 2018-01 Ventilation and indoor-air quality - Hygiene requirements for ventilation and air-conditioning systems and units

Abbreviations used:

AK-BWA Arbeitskreis Bettgestell- und Wagendekontamination

DIN Deutsches Institut für Normung

EN Europäische Norm

ISO International Organization for Standardardization

Ph. Eur. Pharmacopoeia European

SOP Standard Operating Procedure (Standardarbeitsanweisung der GfPS)

USP United States Pharmacopeia

VDI Verein Deutscher Ingenieure

1 DIN EN ISO/IEC 17025:2018: General requirements for the competence of testing and calibration laboratories

2 Council Directive 93 / 42 / EEC of 14 June 1993 concerning medical devices

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